23 June 2017 - The positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use will now be referred to the European Commission which will review and decide on the grant of a marketing authorisation for Imraldi.

Samsung Bioepis Co., Ltd. today announced that the EMA's CHMP has adopted a positive opinion on Imraldi, a biosimilar candidate referencing Humira(adalimumab), for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

The marketing authorisation application for Imraldi was based on data derived from a randomized, double-blind 52-week Phase III study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomised to receive either Imraldi or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the Imraldi group versus 72.2% in the ADL group. The safety profile of Imraldi was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomised in a 1:1 ratio to continue on ADL or switch to Imraldi, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching from ADL to Imraldi.

Read Samsung Bioepis press release